Stevenage, United Kingdom
Job description
Site Name:
UK - Hertfordshire - Stevenage, UK – London – New Oxford Street Posted Date:
Nov 15 2024
Please note this role requires to be based in a UK GSK site for a minimum of 2 days per week. Are you a Nephrology Physician looking to partner with world renowned experts - bringing cutting edge science and technology to aid in the development of novel treatments for patients? This Director role in our Respiratory & Immunology Research Unit (RIRU) may be of interest. Our RIRU is committed to leading the way in Respiratory & Immunology Clinical Research, harnessing the power of the immune system, patient biology and predictive technologies. We are focused on bridging the gap between research and clinical practice to maximise pipeline value and enhance patient lives globally. A
Clinical Development Director - Nephrology
is sought to provide clinical and scientific insights to the Nephrology franchise including emerging indications and adjacencies. You will work within project teams to plan and assure delivery of clinical research and development activities. You will work closely with research members to define the best clinical indication for a target and integrate inputs from across disciplines (scientific, clinical, commercial, regulatory) to contribute to the Early Medicine Profile, Target Validation plans, and Candidate Selection. You will work with early and late development teams to plan clinical development programs and facilitate close collaboration between diverse groups within the Respiratory & Inflammation Research Unit. The responsibilities of the
Clinical Development Director - Nephrology
include (but are not limited to) several key areas: Designing and leading, as appropriate, clinical development protocols/studies/programs in Nephrology across all phases of development, as required by business imperatives as part of clinical and medicine development matrix teams. Clinical development strategy including study Ph1-2/3 design. Providing clinical expert input into regulatory documentation and leading regulatory interactions from clinical perspective for their studies/indications, as appropriate. Working closely with Research Unit members to define prioritized clinical indications for early targets and integrate inputs from across disciplines (scientific, clinical, commercial, regulatory and stats) to contribute to the Medicine Profile, Target Validation, Translational Plans, Candidate Selection, clinical development plan and integrated evidence plan. Design and delivery of an early clinical development plan that effectively demonstrates proof of mechanism, potential efficacy, and a safety profile to support progression to full development. Leading the integrated evidence planning to address the needs of regulators, payors, and patients. Participating/leading the clinical Team (CT) (or equivalent cross-functional clinical team) and Integrated Evidence Team (IET). Engaging external academic and clinical experts to enhance quality and delivery of clinical programs/studies. Providing clinical input into presentations, supporting documentation for and participation in the governance bodies presentations, as requested. Accountability for escalation of clinical safety incidents to the Immunology Clinical Research and Early Programs Head and GSK Pharmacovigilance, as appropriate. Clinical input to regulatory documentation to support the desired indication (e.g., IB, IMPD). Responsibility for addressing clinical questions at meetings with regulatory authorities/ethics committees. Accountability for regulatory reporting requirements including Development Safety Update Reports (DSUR’s) and IB updates. Accountable for incorporating patient perspective in the design and conduct of clinical studies. Medical Governance across the project to ensure scientific integrity and overall safety of the study subjects across all studies and other GSK activities/functions impacting safety and efficacy (i.e., manufacturing, formulation, etc.). Providing medical monitoring and oversight of the safety of study participants on behalf of the Sponsor during the study and, together with the Safety Pharmacovigilance Physician, providing input into aspects of study design that relate to subject safety. Leadership Experience in drug development and/or translational medicine, preferably with industry experience. You will be expected to work across multiple projects and be independently accountable for your own projects. Provide input into disease area strategy and be capable of executing this strategy based on your own expertise and that gained from your network. Play a leadership role in medical governance initiatives in R&D (e.g., safety panel or governance board) or in professional networks in/outside of GSK. Mentoring and coaching other members of Clinical Research and Early Programs Immunology – applying extensive knowledge of clinical development to more than one research unit/disease area. External networking with academia/pharma, bringing expertise back to GSK. You will be able to anticipate, communicate, and suggest solutions on trends/events outside GSK that affect our business direction. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Primary medical qualification (i.e. medical degree) and a clinical medical specialty qualification. Significant proven clinical or scientific expertise in nephrology. Industry or Academic experience in translational medicine and early/late phase drug development; experience of setting and executing scientific strategy, whilst being mindful of overall goals. Understanding and knowledge of early/late drug development and translational sciences. Preferred Qualifications: Please note the following skills are not necessary, just preferred, if you do not have them, please still apply: Primary medical qualification (i.e. medical degree) and PhD with a clinical medical specialty qualification (e.g., fellowship) in nephrology. Experience in working with relevant regulatory bodies and professionals in early/late-stage discovery and development. Project Management experience. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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UK - Hertfordshire - Stevenage, UK – London – New Oxford Street Posted Date:
Nov 15 2024
Please note this role requires to be based in a UK GSK site for a minimum of 2 days per week. Are you a Nephrology Physician looking to partner with world renowned experts - bringing cutting edge science and technology to aid in the development of novel treatments for patients? This Director role in our Respiratory & Immunology Research Unit (RIRU) may be of interest. Our RIRU is committed to leading the way in Respiratory & Immunology Clinical Research, harnessing the power of the immune system, patient biology and predictive technologies. We are focused on bridging the gap between research and clinical practice to maximise pipeline value and enhance patient lives globally. A
Clinical Development Director - Nephrology
is sought to provide clinical and scientific insights to the Nephrology franchise including emerging indications and adjacencies. You will work within project teams to plan and assure delivery of clinical research and development activities. You will work closely with research members to define the best clinical indication for a target and integrate inputs from across disciplines (scientific, clinical, commercial, regulatory) to contribute to the Early Medicine Profile, Target Validation plans, and Candidate Selection. You will work with early and late development teams to plan clinical development programs and facilitate close collaboration between diverse groups within the Respiratory & Inflammation Research Unit. The responsibilities of the
Clinical Development Director - Nephrology
include (but are not limited to) several key areas: Designing and leading, as appropriate, clinical development protocols/studies/programs in Nephrology across all phases of development, as required by business imperatives as part of clinical and medicine development matrix teams. Clinical development strategy including study Ph1-2/3 design. Providing clinical expert input into regulatory documentation and leading regulatory interactions from clinical perspective for their studies/indications, as appropriate. Working closely with Research Unit members to define prioritized clinical indications for early targets and integrate inputs from across disciplines (scientific, clinical, commercial, regulatory and stats) to contribute to the Medicine Profile, Target Validation, Translational Plans, Candidate Selection, clinical development plan and integrated evidence plan. Design and delivery of an early clinical development plan that effectively demonstrates proof of mechanism, potential efficacy, and a safety profile to support progression to full development. Leading the integrated evidence planning to address the needs of regulators, payors, and patients. Participating/leading the clinical Team (CT) (or equivalent cross-functional clinical team) and Integrated Evidence Team (IET). Engaging external academic and clinical experts to enhance quality and delivery of clinical programs/studies. Providing clinical input into presentations, supporting documentation for and participation in the governance bodies presentations, as requested. Accountability for escalation of clinical safety incidents to the Immunology Clinical Research and Early Programs Head and GSK Pharmacovigilance, as appropriate. Clinical input to regulatory documentation to support the desired indication (e.g., IB, IMPD). Responsibility for addressing clinical questions at meetings with regulatory authorities/ethics committees. Accountability for regulatory reporting requirements including Development Safety Update Reports (DSUR’s) and IB updates. Accountable for incorporating patient perspective in the design and conduct of clinical studies. Medical Governance across the project to ensure scientific integrity and overall safety of the study subjects across all studies and other GSK activities/functions impacting safety and efficacy (i.e., manufacturing, formulation, etc.). Providing medical monitoring and oversight of the safety of study participants on behalf of the Sponsor during the study and, together with the Safety Pharmacovigilance Physician, providing input into aspects of study design that relate to subject safety. Leadership Experience in drug development and/or translational medicine, preferably with industry experience. You will be expected to work across multiple projects and be independently accountable for your own projects. Provide input into disease area strategy and be capable of executing this strategy based on your own expertise and that gained from your network. Play a leadership role in medical governance initiatives in R&D (e.g., safety panel or governance board) or in professional networks in/outside of GSK. Mentoring and coaching other members of Clinical Research and Early Programs Immunology – applying extensive knowledge of clinical development to more than one research unit/disease area. External networking with academia/pharma, bringing expertise back to GSK. You will be able to anticipate, communicate, and suggest solutions on trends/events outside GSK that affect our business direction. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Primary medical qualification (i.e. medical degree) and a clinical medical specialty qualification. Significant proven clinical or scientific expertise in nephrology. Industry or Academic experience in translational medicine and early/late phase drug development; experience of setting and executing scientific strategy, whilst being mindful of overall goals. Understanding and knowledge of early/late drug development and translational sciences. Preferred Qualifications: Please note the following skills are not necessary, just preferred, if you do not have them, please still apply: Primary medical qualification (i.e. medical degree) and PhD with a clinical medical specialty qualification (e.g., fellowship) in nephrology. Experience in working with relevant regulatory bodies and professionals in early/late-stage discovery and development. Project Management experience. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
#J-18808-Ljbffr
